- Bristol Myers Squibb (Princeton, NJ)
- …to every treatment we pioneer. Join us and make a difference. The Senior Manager, Clinical Data Management ( Data Management Lead) is a role considered ... BMS R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, ...audits + Provides coaching and quality oversight of junior Data Management Leads **FSP/ CRO /Vendor Oversight** + May… more
- Pfizer (Collegeville, PA)
- …**What You Will Achieve** It is our mission to strengthen the oversight of our clinical data through stronger ownership, control , and visibility of our ... data and records. You will be organizing clinical data forms from therapeutic groups and...applications. **Nice-to-Have** + Master's degree + Contract Research Organization { CRO } and vendor oversight experience + Proficient in using… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12521BR** **Title:** Sr. Manager, Clinical Data Management **Job Description:** The Senior Manager, CDM oversees clinical data management activities ... management processes to ensure complete, accurate, high quality clinical data and adhering to Good ...data - management experience in the pharmaceutical, device or CRO setting. 3. Previous supervisory experience. 4. Proven ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Manager, Clinical Data Standards is responsible for the development and sustainability ... of the Global Clinical Data Standards for quality submissions and...a medical device, pharmaceutical company, or similar environment (eg, CRO ); oncology, immunology, or complex disease therapeutic area experience… more
- Bristol Myers Squibb (Seattle, WA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . The **Senior Manager, Clinical Data Management** is a leadership role considered essential ... not limited to:** Project Management and Leadership * Provides clinical data management leadership within the study...audits * Provides coaching and quality oversight of junior Data Management Leads FSP/ CRO /Vendor Oversight + May… more
- Regeneron Pharmaceuticals (Armonk, NY)
- We are looking for a Clinical Data Manager who will serve as the DM study lead and point of contact for clinical study teams and external partners, (eg, ... adhering to all applicable policies and procedures. As a Clinical Data Manager, a typical day might...to SDMs + Perform & document the oversight of CRO data management activities for assigned studies.… more
- Actalent (Parsippany Troy Hills, NJ)
- Job Description Clinical Data Manager who will work...all data management functions. Manage coordination of CRO data manager and project team to ... collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations… more
- Pfizer (New York, NY)
- …Late-Stage Clinical Scientist (non-MD, Manager) will have an emphasis on performing clinical data review in support of scientific oversight, data ... within the Late-Stage Oncology portfolio. **ROLE RESPONSIBILITIES** + Responsible for performing clinical data review in support of scientific oversight, data… more
- Sumitomo Pharma (Columbus, OH)
- …and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data . + Serves as ... clinical trials including budget and timelines. + Monitors the status of clinical data collection of assigned clinical trials. + Prepares potential… more
- Bristol Myers Squibb (Summit, NJ)
- …ctivities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review ... more: careers.bms.com/working-with-us . **Functional Area Description** The Early Development Clinical Scientist function provides scientific expertise necessary to design… more
- University of Pennsylvania (Philadelphia, PA)
- …for IITs where collaborating physician is the Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; ... research performed. He/she will be responsible for all aspects of clinical trial coordination including: subject recruitment, detailed data entry, subject… more
- Lilly (IN)
- … trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in depth ... and Analytics colleagues such as the CRF Standards Lead, Clinical Data Manager and other key stakeholders...management, database programming or system validation experience in the clinical , pharmaceutical, biotech, CRO or regulatory agency… more
- University of Pennsylvania (Philadelphia, PA)
- …for IITs where collaborating physician is the Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; ... will be responsible for the coordination of complex oncology clinical research protocols, including accurate data collection...and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...+ Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… more
- J&J Family of Companies (Danvers, MA)
- …the status of study progress and activities. + Partner with cross-functional team (eg, clinical data management, medical teams) with query management, data ... focuses on future development of the Impella platform, including clinical studies, data science and new ...regulatory requirements. + Manage monitoring progress of contract & CRO CRAs for respective sites. + Develop and deliver… more
- Pfizer (Collegeville, PA)
- …**What You Will Achieve** It is our mission to strengthen the oversight of our clinical data through stronger ownership, control , and visibility. You will ... play an important role in processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside… more
- AbbVie (South San Francisco, CA)
- …in cross-functional teams to generate, deliver, interpret and communicate high-quality clinical data supporting overall product scientific and business strategy. ... on the pre- clinical (eg mechanism of action, animal models) and clinical (eg epidemiology, diagnosis, treatment) data relevant to program. Engage opinion… more
- Sanofi Group (Cambridge, MA)
- …sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP + Ensure clinical data meets all necessary regulatory standards + Participates in ... investigator meetings + Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety,...and written) + 3 years in pharmaceutical industry or CRO , previous experience in clinical development +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …educational materials, trainings) + In collaboration with Clinical Study Team (CST), executes clinical data reviews and activities prior to data cuts as ... The Medical Director, Clinical Development is responsible for facilitating assigned studies,...of EDC data base and edit check specifications/ data review listing specifications + Communicates with CRO… more